A Novel, Low-Cost Device to Guide Peripherally Inserted Central Catheter (PICC) Line Placement

摘要 仅在美国，就放置了超过300万个外周插入中心静脉导管（PICC 每年提供IV治疗，其中通常通过静脉系统的导航是盲目进行的，或 没有导航。不适当的PICC放置相对常见，成本高，并且具有严重的 重症患者的并发症。不幸的是，在盲置下，30-55%的PICC尖端不是最佳的。 第一次尝试时放置，需要重新定位，平均直接成本为每位患者223美元， 通常需要移除和重新插入导管管线，这会带来4-6%的气胸风险。 此外，大约17%的这些不正确定位的PICC被放置在右心房中，这是不正确的。 伴随着大量危及生命的并发症PICC的不当放置也常常需要 转诊到介入放射科医生进行透视引导中心线放置，费用昂贵 （1,000美元），并需要更多的辐射暴露的病人。毫不奇怪，超过一半的PIC 给60岁以上的病人服用。因此，安全和准确的PICC放置对于提供 为美国老年人提供高质量的医疗服务。尽管与PICC盲置相关的严重不良事件 但是，目前的血管通路系统尚未被广泛采用。Teleflex ARROW® G4 VPS和 Bard Sherlock 3CG® TCS是PICC引导系统，其采用ECG将PICC尖端定位到导管中。 正确位置：包括下上级腔静脉（SVC）和腔房交界处（CAJ）的区域。而 这些手术通常限制了对确认X线的需要，它们的成功放置较差且可变 费率（44-84%），比标准PICC贵30-70%，需要熟练的工作人员， 与标准盲法PICC置入相比，手术时间更长。此外，这些导航系统 依赖于使用心电图，这是无效的患者心律失常，一个条件，影响 大约16%的患者需要PICC导管。为了满足准确，安全和成本的需求- 为了有效放置PICC，Piccolo Medical开发了Smart PICC™系统，一种即时护理导管 使用不同血管区域的独特血液动力学特征进行实时血管通路的系统 引导进入SVC/CAJ。第二阶段提案的目标是验证Piccolo Smart的准确性 PICC™用于导航和将PICC尖端置入SVC或CAJ，适用于有和无 心律失常首先，我们将验证智能PICC™系统算法的灵敏度，以正确识别 在心律正常和改变的成人患者中放置PICC（目的1）。第二，我们将比较 智能PICC™系统的准确性与最广泛使用的导管导航系统（BD的Sherlock 3CG® TCS）进行头对头优效性研究（目标2）。获得的数据将支持FDA 510（k）批准 并将使我们能够在本提案获得资金后的2.5年内将该系统商业化。

Abstract In the United States alone, more than three million peripherally inserted central catheters (PICCs) are placed each year to provide IV therapies, where navigation through the venous system is typically performed blind, or without navigation guidance. Improper PICC placement is relatively common, is costly, and has serious complications for critically-ill patients. Unfortunately, under blind placement 30-55% of PICC tips are not optimally placed on the first attempt and require repositioning, which has an average direct cost of $223 per patient and often necessitates the removal and reinsertion of the catheter line that carries a 4-6% risk of pneumothorax. Moreover, approximately 17% of these improperly positioned PICCs are placed into the right atrium, which is associated with a multitude of life-threatening complications. Improper placement of PICCs also often requires referral to an interventional radiologist for fluoroscopic-guided central line placement, which is expensive ($1,000) and requires more radiation exposure for the patient. Not surprisingly, over half of all PICCs are administered to patients over the age of 60. Therefore, safe and accurate PICC placement is critical for providing high-quality care to older Americans. Despite serious adverse events associated with blind placement of PICC lines, current vascular access systems have not been widely adopted. The Teleflex ARROW® G4 VPS and the Bard Sherlock 3CG® TCS are PICC guidance systems that employ ECG for positioning the PICC tip into the correct location: the region that includes the lower superior vena cava (SVC) and cavoatrial junction (CAJ). While these procedures often limit the need for a confirmatory X-ray, they have poor and variable successful placement rates (44-84%), are 30-70% more expensive than standard PICCs, require skilled staff, and have significantly longer procedure times as compared to standard, blind PICC placement. Additionally, these guidance systems rely on the use of ECG, which is ineffective for patients with cardiac arrhythmias, a condition that affects approximately 16% of all patients requiring a PICC line. To address the need for accurate, safe, and cost- effective PICC placement, Piccolo Medical has developed the Smart PICC™ system, a point-of-care catheter system that uses unique hemodynamic signatures of different vascular regions for real-time vascular access guidance into the SVC/CAJ. The goals of this Phase II proposal are to validate the accuracy of the Piccolo Smart PICC™ for navigation and placement of a PICC tip into the SVC or CAJ for adult patients with and without cardiac arrhythmias. First, we will verify the sensitivity of the Smart PICC™ system algorithm to identify correct PICC placement in adult patients with both normal and altered cardiac rhythms (Aim 1). Second, we will compare the accuracy of the Smart PICC™ system to the most widely used catheter navigation system (BD’s Sherlock 3CG® TCS) in a head-to-head superiority study (Aim 2).The data obtained will support FDA 510(k) clearance and will allow us to commercialize the system within ~2.5 years of the funding of this proposal.